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Gardasil effective against anal cancer

Merck's Gardasil has shown to be effective in preventing HPV-related anal cancer, according to results from a phase III trial

Merck has announced that data from a phase III trial shows Gardasil to be effective in the prevention of anal intraepithelial neoplasia (AIN) associated with human papillomavirus (HPV) types 6, 11, 16 and 18 in men, aged 16-to-26, who have sex with men.

The randomised, double-blind, placebo-controlled trial involved a total of 598 men, aged between 16 and 26, who have sex with men. Each member of the trial received at least one dose of either Gardasil (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) or placebo at the time of enrolment, and then again at two and six months.

Data from the trial showed that Gardasil prevented 77.5 per cent of HPV 6, 11, 16, and 18-related AIN and anal cancer. During the study, a total of 29 men were diagnosed with HPV 6, 11, 16 or 18-related AIN during the study. Twenty-four cases were in the placebo group, and five in the vaccine group. No cases of HPV 11 or 18-related AIN were observed in the vaccine group. No cases of anal cancer were seen in either the placebo or vaccine group.

"We are excited to learn more about the potential of Gardasil to help prevent HPV and HPV-related cancers and diseases in both men and women," said Dr Richard M Haupt, executive director of Merck Research Laboratories.

In the US, Gardasil  is approved for the prevention of cervical, vulvar and vaginal cancers caused by types 16 and 18 HPV, in girls and women aged nine to 26. The drug is also approved to treat genital warts caused by HPV types 6 and 11; and precancerous or dysplastic lesions caused by HPV types 6, 11, 16 and 18.

The drug is also approved in the US for the prevention of genital warts (condylomata acuminata) caused by HPV types 6 and 11 in boys and men aged nine to 26.

The UK's HPV vaccination programme uses GlaxoSmithKline (GSK)'s Cervarix, although Gardasil is approved for use outside of the national immunisation programme.

Gardasil is approved for use, and is marketed as Silgard, in the EU.

18th February 2010

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